What happened
Original notice title
Mega Pro International 8/25/17
From the archived source record
Food and Drug Administration (FDA) conducted an inspection of your facility located at 267 E 1400 S, Suite 101, St George, Utah , where our investigators found a number of violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21 Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under insanitary conditions that do not meet CGMP regulations for dietary supplements. Based on our review, we have concluded that certain products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101. Unapproved New Drugs FDA reviewed your website at the internet address www.mega-pro.com in May, 2017, and have determined that you take orders there for your products, including Chromium Picolinate, Creatine, and DHEA. Additionally, a drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your Chromium Picolinate and Creatine products fail to bear adequate directions for their intended use and, therefore, they are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Adulterated Dietary Supplements Even if your Chromium Picolinate, Creatine, and DHEA products did not have therapeutic claims which make them unapproved new drugs, these products, and your Mega Cut Fat Burner,Stim & Trim Fat Inferno, and Inosine would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] because the products have been held under conditions that do not meet the requirements of Current Good Manufactur
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- a4cb119c0b20
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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